510(k) K163144
K163144 is an FDA 510(k) premarket notification submitted by Gke-GmbH for the device "gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)". The FDA issued a decision of Substantially Equivalent on Apr 7, 2017. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 7, 2017
- Date Received
- Nov 9, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indicator, Biological Sterilization Process
- Device Class
- Class II
- Regulation Number
- 880.2800
- Review Panel
- HO
- Submission Type
- 510(k)